Method for anchoring suture and approximating tissue

ABSTRACT

An elastically curved suture anchor is resiliently straightened and delivered into tissue by a needle. When the needle is withdrawn, resumption of the curvature provides leverage for anchor rotation as the attached suture is pulled to fasten the anchor within the tissue. A fin at the proximal end of the anchor further increases the rotational leverage and expedites anchor fastening. When two or more anchors with connecting suture are delivered in series on a needle, the tension of the suture helps to draw the anchors together and approximates the pierced tissue.

CROSS REFERENCES

This application is a divisional application of U.S. Ser. No.10/914,059, now U.S. Pat. No. 7,766,939, filed on Aug. 5, 2004.

FIELD OF INVENTION

This invention relates to minimally invasive methods for insertingsuture anchors and approximating tissues.

BACKGROUND

Suture anchors have been developed for anchoring sutures in endoscopicor arthroscopic surgery through single sided access. Most prior artsuture anchors are delivered from a lumen of a needle or a tubulardevice. Prior art include U.S. Pat. No. 4,235,238 by H. Ogiu et al.,issued on Nov. 25, 1980, U.S. Pat. No. 4,741,330 by J. Hayhurst, issuedon May 3, 1988, U.S. Pat. No. 4,669,473 by W. Richards et al., issued onJun. 2, 1987, U.S. Pat. No. 5,800,445 by K. Ratcliff et al., issued onSep. 1, 1998, U.S. Pat. No. 5,041,129 by J. Hayhurst et al., issued onAug. 20, 1991, U.S. Pat. No. 5,845,645 by P. Bonutti, issued on Dec. 8,1998, U.S. Pat. No. RE36,974, reissued on Nov. 28, 2000, and U.S. Pat.No. 6,312,448 by P. Bonutti, issued on Nov. 6, 2001. Since the anchorsreside within the lumen of the delivery device, the size of the needlesor tubular members is correspondingly larger, making tissue penetrationmore difficult and traumatic.

Several prior art anchors reside outside and around a needle. Fordelivery, a push rod is used to push along one side of the sutureanchor, sliding along the needle into the tissue. A suture connected atthe opposite side of the push rod is used to pull the anchor as theanchor is being pushed by the push rod. A series of patents by P.Bonutti, U.S. Pat. No. 5,814,072, issued on Sep. 29, 1998, U.S. Pat. No.5,948,002, issued on Sep. 7, 1999, U.S. Pat. No. 6,033,430, issued onMar. 7, 2000 and US patent application publication numberUS2001/0002440, publication date: May 31, 2001, proposed the push andpull method to pivot the anchor within tissue. Pivoting of an anchorwithin tissue is classified as partial-thickness suture fastening. Tofacilitate instant pivoting, the suture is connected close to bothdistal and proximal ends of the anchor to provide favorable leverage foranchor rotation. FIG. 1 depicts the prior art 235, which has completedthe rotation within tissue. The suture 122 is looped near or at bothends of the anchor 235, as depicted in the prior art patents. Forfavorable leverage, the strands of suture 122 connected to the anchor235 are widely spaced apart. As tension is applied to the suture 122,the strands of suture 122 spread open, as indicated by the shaded area236, opening or pushing out the tissue 130 along the path of anchor 235entry. Especially within soft tissue, the widely spaced sutures 122wedge open the tissue directly above the anchor 235. As a result, thepullout strength of the anchor 235 is likely to be low. The probablemode of failure is likely to be anchor 235 pullout, as depicted in FIG.2, rather than suture 122 breakage. While the widely spaced suture 122provides favorable leverage for rapid rotation, it appears to sacrificethe strength of tissue anchoring.

Another prior art suture anchor, U.S. Pat. No. 5,626,614 by C. Hart,issued on May 6, 1997, also resides outside and around a needle. Hart'sinvention is designed for fastening or proximating tissues separated bytwo distinct walls, such as the stomach and abdominal walls, usingfull-thickness fastening. Unfortunately, most tissue within the bodyadheres to adjacent tissue with no clear separation, space or cavity.Therefore, full-thickness anchor pivoting to fasten or proximate twotissues has limited use.

SUMMARY OF INVENTION

Organs and/or tissues, especially in urology, are virtually adhere toeach other. This invention is capable of anchoring a suture in eitherpartial- or full-tissue thickness fastening, without the cumbersomemanipulations of the suture or delivery device as described in priorart. In addition, the suture anchor contains a platform designed toimprove anchoring strength within tissue.

A curved anchor made with elastic material contains a lumen for theneedle. A fin protrudes from one side and a platform covers the oppositeside of the anchor. The fin is on the concave side and at the proximalend, while the platform is on the convex side of the curved anchor. Asuture passes through an opening in the platform, loops around theconcave side of the anchor, and exits through another opening in theplatform. As a result, both strands of the suture can be pulled from theconvex side of the anchor.

The suture anchor is resiliently straightened by a rigid needle insertedthrough the lumen of the anchor. The needle contains a widened portionor a step to prevent the anchor from sliding up the needle. The needleis used to deliver the anchor by puncturing into tissue. At a properdepth, the needle can then be withdrawn. The protruded fin is taperedfor tissue insertion, but behaves as a tissue snagging barb, hookingonto the tissue and resisting pullout. As a result, the needlewithdrawal strips the anchor off the needle, and at the same timedeploys the anchor within the tissue at the proper depth.

The anchor resumes the elastic curvature within the tissue afterwithdrawal of the rigid needle. The fin at the proximal end of theconcave curvature is laterally pressed into the adjacent tissue, whilethe central portion of the convex curvature connecting to the suture ispushed in the opposite direction further away from the fin. In essence,curvature resumption within tissue increases the distance between thefin and the openings for the suture, as the fin is pressed laterallyinto the tissue. When the strands of suture are pulled on the convexside of the anchor, the curved anchor begins to rotate within tissuefrom a vertical, or inserting position, to a horizontal, or fasteningposition. The platform is also repositioned from vertical to horizontalto greatly resist pullout during tissue fastening and repair.

Multiple anchors can be linked by a suture and delivered in series intotissue. When the suture is pulled, the anchors draw close to each otherto shorten or approximate the pierced tissue.

REFERENCE NUMBER

-   100 Intervertebral disc-   101 Urethra-   102 Urethropelvic ligament-   103 Stepped or smooth needle-   104 Lumen of suture anchor-   109 Plunger-   111 Disc compressor-   112 Bladder neck-   113 Mucosa-   114 Vagina-   115 Pubic symphysis-   117 Urine-   118 Cancellous bone-   119 Annular contact surface-   122 Suture-   123 Opening for suture-   125 Suture knot-   126 Cortical bone-   127 Bladder-   128 Nucleus pulposus-   130 Soft tissue-   131 Lateral wall of urethra-   132 Rectum-   133 Platform of anchor-   134 Fin of anchor-   138 Tendon or ligament-   144 Suture anchor-   150 Lumen of urethra-   151 Posterior wall of urethra-   152 Anterior wall of urethra-   153 Needle indentation-   154 Catheter-   155 Bend stop-   156 Gap of bend stop-   157 Incision-   159 Handle of positioning device-   160 Lifting hand piece-   161 Uterus-   163 Uterus positioning tool-   164 Suture attachment-   165 Step of trocar or needle-   171 Distal round end-   172 Shaft of positioning device-   185 Trocar guide-   188 Psoas major muscle-   196 Retractor-   220 Sleeve of trocar or needle-   221 Grippers on the sleeve-   235 Prior art suture anchor-   236 Area of suture spread-   237 One-way grip-   238 Suture passage of the grip-   239 Suture lock-   240 Cone hole-   241 Gripper-   245 Knot pusher-   246 Inner tube-   247 Outer tube-   248 Side window-   249 Sharp edge-   250 Suture cutting device-   251 External sphincter-   252 Internal sphincter-   253 Cardinal ligament-   254 Sacrouterine ligament-   255 Fascia-   256 Ovary-   257 Round ligament-   258 Fallopion tube-   259 Grasping device-   260 Guide arm-   261 Pointer-   262 Glide track-   263 Endoscope-   264 Suture gripping device-   265 Flap-   266 Cone-   267 Loop-   268 Scar tissue-   269 Lumen of needle-   270 Collagen bundles-   271 Cervix-   272 Adipose tissue-   273 Approximating device-   274 Retropubic space-   275 Body of anchor

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the tissue 130 opening above the prior art anchor 235,caused by spreading 236 of the sutures 122 as tension is applied.

FIG. 2 depicts prior art anchor 235 pullout as a probable result of thetissue 130 opening directly above the prior art anchor 235.

FIG. 3 depicts a suture anchor 144 with an elastically curved body 275,lumen 104, a fin 134, a relatively flat platform 133 and two openings123 for a suture 122.

FIG. 4 depicts the elastic body 275 being resiliently straightened by atrocar or needle 103 inserted through the lumen 104 of the anchor 144.

FIG. 5 depicts the resiliently straightened anchor 144 resting on a step165 of the needle 103.

FIG. 6 shows a side view of the anchor 144 with the stepped needle 103.The distal tip of the anchor 144 is beveled. The platform 133 and fin134 are tapered for tissue penetration.

FIG. 7 depicts the top view of the anchor 144 with suture 122 exitingfrom openings 123 on the elliptical platform 133 tapered at both distaland proximal ends.

FIG. 8 shows the bottom view of the anchor 144, indicating the tapereddistal tip, and looping of the suture 122 under the anchor 144 todistribute suture 122 tension.

FIG. 9 depicts the rotational direction of the curved suture anchor 144within tissue, as tension is applied to suture 122.

FIG. 10 depicts penetration of the stepped needle 103 loaded with thesuture anchor 144 into soft tissue 130.

FIG. 11 depicts the anchor 144 resuming the curved configuration andpressing the fin 134 laterally into the tissue 130 after the withdrawalof the stepped needle 103.

FIG. 12 depicts tension applied to the suture 122 pulling on the curvedanchor 144 and driving the fin 134 further laterally.

FIG. 13 depicts the tension driven rotation of the anchor 144, orientingthe large and relatively flat platform 133 from a vertical to ahorizontal position to resist anchor 144 pullout.

FIG. 14 indicates a normal, well-supported bladder 127 in dashed linesand a descended bladder 127 with a widened bladder neck 112 in solidlines.

FIG. 15 shows a failed lumen 100 closure and hypermobility under stresswith the urethropelvic ligament 102 pulling the lateral walls 131 of thepoorly supported urethra 101.

FIG. 16 indicates a mid-longitudinal view of FIG. 15 and urine 117leakage during stress with urethropelvic ligaments pullingperpendicularly above and below the plane of the page.

FIG. 17 shows a prior art procedure for treating urinary incontinencethrough a large incision 157 for passing sutures 122 and pulling thevagina 114 forward to support or compress the posterior wall of theurethra 101.

FIG. 18 depicts a section of the surgically corrected urethra 101 withsutures 122 pulling the vaginal 114 tissue to support and gentlycompress the urethral posterior wall 151.

FIG. 19 indicates lumen 150 closure of the surgically corrected urethra101 under stress, with urethropelvic ligaments 102 pulling the lateralwalls 131 of the supported urethra 101.

FIG. 20 shows a small incision 157 for inserting the stepped needle 103with the suture anchor 144 into the vaginal wall.

FIG. 21 depicts the urethral posterior wall 151 supported by sutures 122and anchors 144 within the vagina 114.

FIG. 22 indicates a proximal end of a suture anchor 144 with anelliptical lumen 104, sized and configured to fit over a stepped needle103 with an elliptical cross-section.

FIG. 23 shows a lengthened fin 134, sized and configured to fit into anindentation 153 on a stepped needle 103.

FIG. 24 depicts a uterine 161 prolapse.

FIG. 25 depicts a repositioned uterus 161 pierced with the steppedneedle 103 through a small incision 157.

FIG. 26 depicts uterus 161 fastening with sutures 122 and anchors 144.The suture 122 is knotted 125 onto the ligament or fascia on theabdominal wall.

FIG. 27 depicts penetration of the stepped needle 103 with the sutureanchor 144 through a torn ligament 138 into decorticated bone 118.

FIG. 28 depicts the suture anchor 144 resuming some of the curvedconfiguration within the bone 118 after being dislodged from thewithdrawn stepped needle 103.

FIG. 29 depicts suture 122 tension driving the fin 134 further laterallyinto the bone 118.

FIG. 30 depicts another anchor 114 delivered by the stepped needle 103through the torn ligament 138 into cancellous bone 118.

FIG. 31 depicts a suture knot 125 tied to fasten the torn ligament 138onto the bone.

FIG. 32 shows a bend stop 155 with a closed gap 156 beneath the platform133 to prevent excessive anchor 144 bending under significant suture 122tension.

FIG. 33 shows a stepped needle 103 resiliently straightening the anchor144 with the bend stop 155. In the straightened position, the gap 156 isopen.

FIG. 34 depicts a side view of the straightened anchor 144 with an opengap 156 beneath the platform 133.

FIG. 35 indicates a bottom view of the straightened anchor 144 showingbend stops 155 with open gaps 156 beneath the platform 133.

FIG. 36 shows a straight anchor 144 with a large fin 134 and a taperedproximal end.

FIG. 37 shows a side view of the straight anchor 144, as shown in FIG.36, with dimensions W₁, L₁ and L₂.

FIG. 38 shows another straight anchor 144 with elevated suture openings123.

FIG. 39 shows a side view of the anchor 144 with elevated sutureopenings 123, as shown in FIG. 38, with dimensions W₂, L₁ and L₂.

FIG. 40 depicts a curved suture anchor 144 with a protruded sutureattachment 164, a fin 134 and a small platform 133.

FIG. 41 depicts another curved suture anchor 144 with the protrudedsuture attachment 164 but without a platform.

FIG. 42 shows a curved suture anchor 144 without a fin.

FIG. 43 depicts a curved suture anchor 144 with a platform 133 on theconcave side of the curvature. The fin 134 is made blunt.

FIG. 44 shows the suture anchor 144 of FIG. 43 resiliently straightenedby a needle 103 with a sliding sleeve 220.

FIG. 45 depicts penetration of the stepped needle 103 with the sleeve220 to deliver a suture anchor 144 through a bulging intervertebral disc100.

FIG. 46 depicts pushing of the anchor 144 by the sliding sleeve 220 toexpel the suture anchor 144 beyond the distal edge of the disc 100.

FIG. 47 depicts a disc compressor 111 with two openings 123 for a suture122 and a cylindrical or blunt region 119 to compress the disc 100.

FIG. 48 depicts bulge compression by fastening the disc compressor 111with a suture 122 secured by the anchor 144 outside the disc 100.

FIG. 49 depicts portions of two anchors 144 connected by a suture 122 toform an approximating device 273 for tightening or shortening tissue.

FIG. 50 shows a double-stepped 165 needle 103 resiliently straighteningtwo anchors 144 with a suture 122 arrangement similar to FIG. 49.

FIG. 51 indicates deployment of the anchors 144 within tissue afterwithdrawal of the needle 103.

FIG. 52 shows orientation of the suture 122 designed to resist slidingthrough holes 123B and 123G when the anchor 144 is in a vertical orinserting position.

FIG. 53 depicts anchors 144 pivoting within tissue as the suture 122 ispulled.

FIG. 54 shows anchor 144 insertion into tissue 130 with the needle 103,as the initial step for deploying the approximating device 273.

FIG. 55 indicates partial withdrawal of the needle 103 to deploy thedistal anchor 144 within tissue 130.

FIG. 56 depicts proximal anchor 144 insertion by pushing the sleeve 220,and distal anchor 144 pivoting by pulling on the suture 122.

FIG. 57 shows complete insertion of the proximal anchor 144 into thetissue 130 by pushing the sleeve 220 and pulling suture 122.

FIG. 58 indicates withdrawal of the needle and curvature resumption ofthe proximal anchor 144 within tissue 130.

FIG. 59 depicts composition of a suture lock 239 with sutures 122passing through a cone 266 over a one-way grip 237 with individualgrippers 241.

FIG. 60 shows the lock 239 assembly with the suture 122 fastened betweenthe cone 266 and grippers 241. A plunger 109 is used to advance thesuture lock 239.

FIG. 61 indicates pulling on the sutures 122 and pushing on the plunger109 against and lock 239 to draw the anchors 144 together as anapproximating device 273 within tissue.

FIG. 62 depicts knot 125 tying within tissue using a knot pusher 245.

FIG. 63 shows an inner tube 246 containing a channel opening from thedistal end to a side window 248.

FIG. 64 shows an outer tube 247 also containing a channel opening fromthe distal end to a side window 248.

FIG. 65 depicts a suture cutter 250 assembled by fitting the inner tube246 into the outer tube 247 with overlapping side windows 248.

FIG. 66 indicates threading a pair of sutures 122 through the distalopening, out the overlapping side windows 248 of the inner tube 246 andouter 247 tube.

FIG. 67 shows a mid-longitudinal view of the suture cutter 250 withsharp edges 249 at the side windows 248.

FIG. 68 depicts cutting of the suture 122 by the sharp edges 249 as theouter tube 247 slides over the inner tube 246.

FIG. 69 shows a mid-longitudinal view of FIG. 68.

FIG. 70 depicts suture 122 cutting with the cutter 250 after knots 125are tied.

FIG. 71 indicates retraction of an incision 157 to expose a scarred 268external sphincter 251, a common cause of anal incontinence.

FIG. 72 shows cutting of the sphincter 251 in a prior art surgicalprocedure.

FIG. 73 depicts overlapping and suturing the external sphincter 251 totighten the internal sphincteric muscle 252.

FIG. 74 shows a lumen 269 in the needle 103 for delivering radiopaque,echogenic or other tracing agent to guide needle 103 insertion.

FIG. 75 shows tightening of the scarred 268 external sphincter 251 withmultiple approximating devices 273.

FIG. 76 depicts a flexible needle 103 with a tapered tip, as a sewingneedle, for delivering the approximating device 273.

FIG. 77 depicts rotational advancement of the flexible needle 103between collagen bundles 270 of tendon or ligament 138.

FIG. 78 depicts a lumen 269 in the rotational needle 103 for deliveringradiopaque, echogenic or other tracing agent to guide needle 103insertion.

FIG. 79 indicates a cross-sectional view of the uterine 161 supportivestructure, cardinal 253 and sacrouterine 254 ligaments, and fascia 255.

FIG. 80 shows insertions of multiple approximating devices 273 intocardinal 253 and sacrouterine 254 ligaments supporting the uterus 161.

FIG. 81 indicates the ascendant cervix 271 as the result of sutures 122tightening to plicate the cardinal 253 and sacrouterine 254 ligaments.

FIG. 82 depicts partial insertion of the proximal anchor 144 of theapproximating device 273 into tissue 130 by advancing the sleeve 220.

FIG. 83 shows a prior art suture-gripping device 264 with flaps 265biased against the upward tensile force applied to the suture 122.

FIG. 84 indicates the suture gripping device 264 and plunger 109positioned to tighten the anchors 144 of the approximating device 273after withdrawal of the needle.

FIG. 85 depicts fastening of the approximating device 273 by tying knots125 beneath the suture-gripping device 264.

FIG. 86 shows a guide 185 to direct needle 103 insertion along a track262, with an extendible arm 260 and a pointer 261 to indicate thedestination of the needle 103.

FIG. 87 depicts needle 103 insertion through the vaginal 114 wall,lateral to the urethra 101 into fascia 255 and adipose tissue 272.

FIG. 88 indicates support of the posterior urethral wall 151 by theanchors 144 of the approximating devices 273.

FIG. 89 also shows support of the posterior urethral wall 151 bytightening or restricting between fascia covering the anterior urethralwall 152 and the vaginal 114.

FIG. 90 depicts double approximating devices 273 loaded on a singleneedle 103.

FIG. 91 shows fastening of the double approximating devices 273 afterinsertion of a single needle 103.

FIG. 92 shows an inner sleeve 220 for deploying the distal anchor 144and an outer sleeve 220 for deploying the proximal anchor 144 from theneedle 103.

FIG. 93 depicts the proximal end of a platform 133 tapered over theproximal end of the body 275 to facilitate pivoting and rotation withintissue.

FIG. 94 shows the side view of the tapered platform 133 over theproximal end of the body 275 supported by a shape-matching step 165.

DETAILED DESCRIPTION OF THE EMBODIMENTS

A curved anchor 144 is made with elastic material containing alongitudinal lumen or passage 104, a fin 134 at or near the proximalend, and a relatively flat platform 133 on the convex side of thecurvature with two openings 123 for a suture 122, as shown in FIG. 3.Through the openings 123 on the platform 133, the suture 122 is loopedaround the concave side of the curved anchor 144 for tensiondistribution. FIG. 4 depicts a relatively rigid trocar or needle 103inserted through the lumen 104 to resiliently straighten the elasticanchor 144. The needle 103 is marked with measuring units, visible underendoscope, to indicate depth of needle 103 penetration into tissue. Thedistal portion of the needle 103 is sized and configured to fit into thelumen 104 of the anchor 144. To prevent the anchor 144 from sliding upthe needle 103 during tissue penetration, the cross-sectional diameterof the needle 103 is not uniform. A step 165 on the needle 103, as shownin FIGS. 4 and 5, blocks the anchor 144 from sliding upward, over theneedle 103. FIG. 5 depicts the proximal end of the resilientlystraightened anchor 144 resting on the step 165 of the needle 103, withthe fin 134 protruding over or above the step 165. In essence, theelastic suture anchor 144 has a curved position and a straightenedposition.

FIG. 6 depicts a side view of the curved anchor 144 straightened by therigid stepped needle 103. The distal tips of the anchor 144, platform133 and fin 134 are tapered and/or beveled to accommodate tissuepenetration. The proximal end of the fin 134 is designed to resistanchor 144 pull out during withdrawal of the stepped needle 103. FIG. 7depicts the top view of the anchor 144 with an elliptical platform 133tapered at both distal and proximal ends. The tapered distal end of theplatform 133 is designed for tissue penetration spearheaded by thestepped needle 103. FIG. 8 depicts the bottom view with tapered distalends of the anchor 144 and the fin 134 for ease of tissue penetration.The suture 122 passes through the openings 123 on the platform 133 andloops under the straightened anchor 144 to distribute tension of thesuture 122. Since the suture 122 is not tied to the anchor 144, thesuture 122 can slide freely, even after the anchor 144 is fastenedwithin tissue. A sliding suture 144 can be useful, sometimes essentialin tissue reattachment or other surgical manipulations.

The fin 134 serves as a reversed barb or a snag, favoring tissuepenetration but resisting anchor 144 pullout. The anchor 144 isdelivered by tissue piercing with the stepped needle 103, as shown inFIG. 5. The depth of anchor 144 insertion is known by the measuringunits on the stepped needle 103, as shown in FIGS. 4 and 5. As thestepped needle 103 is withdrawn, the barb-like fin 134 catches, hooks orsnags onto the surround tissue, allowing the anchor 144 to slide off thewithdrawn stepped needle 103. The anchor 144 remains in the tissue withthe suture 122 attached. In essence, the anchor 144 is delivered in thetissue simply by inserting and withdrawing the stepped needle 103.

Driven by suture 122 tension, the delivered anchor 144 is designed torotate and fasten within tissue. After withdrawal of the stepped needle103, the anchor 144 resumes the curved configuration, laterally pressingthe pointed proximal end of the fin 134 into the tissue. Three pointscurved anchor 144: the suture openings 123 on top of the platform 133,the fin 134 and the distal end of the anchor 144, form a triangle. Inessence, the lateral separation between the protruded fin 134 and thesuture 122 connecting points or openings 123 increases with resumptionof the anchor 144 curvature. The distance, W, between the sutureopenings 123 and the proximal end of the fin 134, as shown in FIG. 9,provides initial rotational torque, when tension is applied to thesuture 122 by the surgeon. The tapered proximal end of the platform 133is shaped for lateral tissue penetration when the anchor 144 is pulledby the suture 122. The curved arrow in FIG. 9 indicates the rotationaldirection of the anchor 144 within the tissue from vertical to nearhorizontal, about 90°, as a direct response to suture 122 tension, shownas a straight arrow. The fin 134 guides, spearheads and/or prevents theanchor 144 from twisting during rotation or pivoting within tissue,repositioning the platform 133 from being parallel with the suture 122,as shown in FIG. 5, to being near perpendicular with the suture 122 formaximum anchoring power. Anchor 144 rotation within the tissue may alsobe favored if L₁ is longer than L₂, where L₁ is the distance between theproximal end of the anchor 144 to suture openings 123, and L₂ is thedistance between the distal end of the anchor 144 to suture openings123. However, depending on the size and shape of the platform 133, if L₁is significantly longer than L₂, the anchor 144 may over rotate, beyond90°. As a result, the suture 122 would no longer be perpendicular to theplatform 133, and the anchoring strength could possibly weaken.

Partial thickness suturing is common in open surgery, and rotation ofthe curved anchor 144 within the tissue allows the surgeon to obtainpartial thickness suturing in endoscopic, arthroscopic or laparoscopicprocedures. The curved suture anchor 144 is designed for: (1)elastically straightening with the stepped needle 103, (2) tissuepenetration with tapered distal portions, (3) dislodging with thebarb-like fin 134, (4) curvature resumption following needle 103withdrawal, (5) rotation within the tissue driven by suture 122 tension,and (6) anchoring strength with the large platform 133.

FIG. 10 depicts penetration of the stepped needle 103 loaded with thesuture anchor 144 into soft tissue 130. A scale on the stepped needle103 visible to the surgeon measures the depth of anchor 144 insertion.The fin 134 of the anchor 144 protrudes outwardly, catching the tissue130 and preventing the anchor 144 from pulling out as the stepped needle103 is withdrawn. In essence, withdrawal of the stepped needle 103dislodges or strips off the anchor 144, allowing the suture anchor 144to remain at or near the intended depth of insertion. FIG. 11 depictsresumption of the curved configuration of the anchor 144 afterwithdrawal of the stepped needle 103. The curvature also providescompression on the fin 134, embedding the fin 134 laterally into tissue130. FIG. 12 depicts tension applied to the suture 122 to pull androtate the anchor 144 from an insertion or vertical position to ananchoring or horizontal position. The initial lateral mobility isfavored by (1) the curvature of the suture anchor 144, and (2)protrusion of the fin 134. During rotation, twisting of the anchor 144along the longitudinal axis is prevented by the fin 134 and the platform133 as both laterally penetrate into tissue 130. FIG. 13 depicts furthertension applied to the suture 122, orienting the platform 133 to nearlyperpendicular to the suture 122 under tension. With the large surfacearea of the platform 133 pressing against the tissue 130, the suture 122is secured with good anchoring strength for surgical repair. Therotation of the anchor 144 within the tissue provides partial thicknesssuturing with endoscopic, arthroscopic or laparoscopic capability.

It is widely believed that most of the urinary incontinence in women isrelated to a descended position of the bladder 127, the funneling of thebladder neck 112 and/or diminished posterior 151 urethral support. Thedashed line of FIG. 14 indicates the normal position and the solid linedepicts a descended position of the bladder 127 with its funnel-shapedbladder neck 112. FIG. 15 shows a failed lumen 100 closure andhypermobility under stress with the urethropelvic ligaments 102 pullingthe lateral walls 131 of the poorly supported urethra 101. FIG. 16 showsthe mid-sagittal view of FIG. 15 during stress, with urethropelvicligaments pulling perpendicularly above and below the plane of the page.FIG. 16 also indicates that the section of poorly supported posteriorwall 151 withdraws from mucosal 113 coaptation, leading to urine 117leakage.

Numerous existing surgical procedures are designed to treat urinaryincontinence. The traditional surgical treatment for urinaryincontinence is to add backboard support to the urethral posterior wall151, usually by repositioning the vagina 114 with sutures 122. FIG. 17indicates the pre-surgical position of the vagina 114 with a dottedline, and that of the urethra 101 and bladder with dashed lines. FIG. 17also shows a large incision 157 required for repositioning and suturingboth the vagina 114 and urethra 101 toward the abdominal wall. Thepost-surgical positions of the vagina 114 and backboard-supportedurethra 101 are depicted with solid lines. The sutures 122 are knotted125 to fascia or ligament on the abdominal wall. FIG. 18 indicates asection of the backboard-supported posterior wall 151. Thissignificantly invasive procedure provides the backboard support neededfor lumen 150 closure during stress with concurrent pulling of theurethropelvic ligaments 102 to prevent urine leakage, as shown in FIG.19.

Through a much smaller incision 157, the suture anchor 144 system canprovide similar backboard support to the posterior wall 151 of theurethra 101. A catheter 154 is introduced through the urethra 101 intothe bladder 127. The descended bladder 127, depicted in dotted lines, islifted by the pressure against the wall of the vagina 144. Through thevagina 114, the surgeon can also feel the catheter 154 within theurethra 101 to guide the needle/anchor 103/144 insertion lateral to theurethra 101, as shown in FIG. 20, into the vaginal 114 wall. As thestepped needle 103 is withdrawn, the fin 134 hooks onto the vaginal 114tissue, stripping the anchor 144 off the withdrawing needle 103. Themethod of guiding the needle 103 with the surgeon's finger is currentlybeing used with the Stamey needle, a prior art device, for repairingstress urinary incontinence. Unlike the Stamey needle, the needle/anchor103/144 system does not require passing the suture 122 back and forthfrom the vagina 114 cavity to the abdominal wall. Furthermore, thesuture 122 introduced by the Stamey needle is exposed within the vagina,which increases the risk of infection. The suture anchor 144 on theother hand, can be deployed within the vaginal 114 wall, as partialthickness suturing in open surgery. The suture anchor 144 can also bedelivered and deployed in the vaginal 114 cavity, as full thicknesssuturing. FIG. 21 depicts four suture anchors 144 fastened within theanterior vaginal 114 wall, providing backboard support to the posteriorwall 151 of the urethra 101. The sutures 122 from the anchors 144 areknotted to fascia or ligament, similar to FIG. 17, but requiring only amuch smaller incision 157. The orientation of the anchor 144 withintissue can be significant. For example, the anchors 144 deployedperpendicular to the urethra 101, as depicted in FIG. 21, may provide amore firm backboard support than the anchors 144 deployed parallel tothe urethra 101.

To prevent twisting between the anchor 144 and needle 103, the lumen 104of the anchor 144 can be made non-round, elliptical for example, asshown in FIG. 22, with the stepped needle 103 sized and configured tofit the lumen 104. FIG. 23 shows an extended fin 134 sized andconfigured to fit into an indentation 153 on the stepped needle 103.Similarly, an extended portion from the stepped needle 103 can fit intoan indentation in the anchor 144 to prevent the anchor 144 from spinningon the stepped needle 103.

FIG. 24 depicts a patient with uterine 161 prolapse, a common problem inwomen. Uterine 161 prolapse is normally surgically treated withhysterectomy, removal of the uterus 161, either through vaginal orabdominal incision. The following procedure is ideally used inconjunction with the ligament-tightening procedure described in FIGS. 80and 81. FIG. 25 depicts lifting and repositioning of the uterus 161 witha uterine tool 163 containing a blunt distal end 171, a shaft 172, ahandle 159 and a lift 160. The stepped needle 103 with the suture anchor144 is then inserted through a small incision 157, guided by anendoscope, into the repositioned uterus 161. As the stepped needle 103is withdrawn, the fin 134 hooks onto the uterine 161 tissue, dislodgingthe anchor 144 from the withdrawn needle 103. The needle 103 and anchor144 insertion procedure is repeated, and the sutures 122 are knotted 125on the fascia or a ligament on the abdominal wall, as shown in FIG. 26,similar to the suture 122 tying for correcting urinary incontinence.Other supporting structures, such as the round ligament and broadligament of the uterus, may also be suitable for fastening the suture122 to and supporting the repositioned uterus 161.

The suture anchor 144 can also be used in orthopedic repairs. FIG. 27depicts penetration of the stepped needle 103 and anchor 144 through atorn ligament 138 into freshly decorticated cancellous bone 118. Thestepped needle 103 also contains a sleeve 220, freely sliding over thestepped needle 103. The position of the ligament 138 can be manipulatedand maintained with grippers 221 on the distal end of the sleeve 220, asthe stepped needle 103 is withdrawn. During needle 103 withdrawal, thefin 134 acts as a barb, hooking onto the cancellous bone 118, andstripping the anchor 144 off the withdrawing needle 103. FIG. 28 depictscurvature resumption of the suture anchor 144 within the porouscancellous bone 118 after having slid off the withdrawn stepped needle103. FIG. 29 depicts tension applied to the suture 122, pulling on thecurved anchor 144 and driving the fin 134 further laterally. Theplatform 133 of the anchor 144 provides a large surface area to pressagainst the bone 118 and resist pull out. FIG. 30 depicts another anchor114 delivered by the stepped needle 103 through the torn ligament 138into the cancellous bone 118. The stepped needle 103 is then withdrawnwith the second anchor 114 also fastened within bone 118. FIG. 31depicts suture knot 125 tying to fasten the torn ligament 138 onto thebone. In arthroscopic surgery, slip knots 125 are most frequently tiedand delivered to the surgical site with a knot 125 pushing device. Thefastened ligament 138 will eventually heal and reattach onto thecancellous bone 118. In essence, the sutures 122 and anchors 114 aremerely used to maintain the position of the torn ligament 138;reattachment and healing occur naturally with the surgically inflictedbleeding bone 118. Therefore, both the anchors 144 and sutures 122 canbe made with biodegradable materials to prevent device migration withtime.

The anchoring strength of the suture anchor 144 can be further improved.The anchor 144 reaches full anchoring strength as the anchor 144 formsalmost a T-configuration or is perpendicular with the suture 122, asshown in FIG. 13. With excessive tension on the suture 122, the elasticanchor 144 may curve further, or even fold into a V-configuration. As aresult, the anchoring strength would greatly decrease. To prevent theanchor 144 from excessive bending or folding, bend stops 155 can beadded along both sides of the anchor 144 to increase rigidity andanchoring strength of the anchor 144. FIG. 32 depicts the bend stop 155with a gap or V-groove 156 beneath the platform 133. When the sutureanchor 144 is in the curved configuration, the gap 156 is closed toresist further bending of the anchor 144, as depicted in FIG. 32. As theelastic anchor 144 is resiliently straightened by the stepped needle103, the gap 156 is opened, as shown in FIG. 33. FIG. 34 depicts theside view of the resiliently straightened anchor 144, showing the opengap 156 of the bend stop 155 beneath the platform 133. FIG. 35 depictsthe bottom or belly view of the resiliently straightened anchor 144,showing the bilateral bend stops 155 and open gaps 156. The bend stops155 are designed and positioned to limit or resist excessive anchor 144bending to maximize anchoring strength.

A straight and rigid anchor 144 with the fin 134 can also rotate withintissue by utilizing the tension applied to the suture 122. As mentioned,the curvature of the anchor 144, as shown in FIG. 9, increases thedistance, W, to provide additional torque for lateral rotation. For arigid anchor 144, as shown in FIG. 36, a larger and more protruded fin134 may adequately provide torque for the anchor 144 rotation within thetissue. FIG. 37 depicts the side view of the rigid anchor 144 showing adistance, W₁, measured from the proximal tip of the fin 134 to thesuture opening 123. The distance, W₁, provides the initial rotationaltorque as tension is applied to the suture 122 by the surgeon. Byelevating the suture openings 123 from a protrusion, a rigid anchor 144,shown in FIG. 38 with side view in FIG. 39, provides an even greaterdistance, W₂, for greater initial rotational torque. The fin 134 can bemade pointed or angled, as shown in FIGS. 36 to 39 to facilitate lateraltissue penetration and anchor 144 rotation. Rotation of the anchor 144within tissue is also favored when L₁>L₂, where L₁ is the distancebetween the proximal tip of the fin 134 and the suture openings 123, andL₂ is the distance between the distal end of the anchor 144 and thesuture openings 123. The tapered proximal ends, as shown in FIGS. 36 and38, also help to facilitate lateral insertion into tissue during anchors144 rotation.

Several derivatives may provide adequate anchoring strength for thesuture 122. FIG. 40 depicts a suture attachment 164 without threadingthrough the platform 133. For light duty suture 122 anchoring, theplatform 133 may not be necessary. FIG. 41 shows an anchor 144 with thefin 134 but without a platform. FIG. 42 shows a curved anchor 144without a fin. With a curvature built into the anchor 144, it may besufficient to provide initial torque to rotate the anchor 144 withintissue when tension is applied to the suture 122.

The suture anchor 144 may also be used for full thickness anchoring.FIG. 43 depicts a curved suture anchor 144 with a platform 133 on theconcave side of the curvature. The fin 134 is made blunt to avoid damageto adjacent tissue. The anchor 144 is loaded onto the stepped needle 103with a sleeve 220 capable of sliding over the stepped needle 103, asshown in FIG. 44. The sleeve 220 is similar to that shown in FIG. 28 forholding and manipulating tissue. For full thickness suture 122anchoring, the sleeve 220 can also be used to push the anchor 144 offthe stepped needle 103 and deploy the anchor 144 outside the tissue. Theprotruded fin 134 can provide an additional function, as a contact pointfor the sleeve 220. FIG. 45 depicts a cross section of a bulging L4-5intervertebral disc 100 located between psoas major muscles 188. Underfluoroscopic guidance or other means, the stepped needle 103 carryingthe anchor 144, as shown in FIG. 44, is delivered through a smallposteriolateral incision, into the bulging annulus and nucleus pulposus128, as shown in FIG. 45. The advancement of the stepped needle 103stops as the distal tip of the stepped needle 103 exits the disc 100.The sliding sleeve 220 is used to push and expel the anchor 144 with theattached suture 122 out of the disc 100. Especially with a radiopaquecoating on the anchor 144, it is possible to see the orientation of theanchor 144. When tension is applied to the suture 122, the platform 133of the anchor 144 is likely to conform and press against the outersurface of the disc 100, as shown in FIG. 46. Otherwise, the orientationof the anchor 144 can be corrected by advancing the distal tip of thesleeve 220 to manipulate the anchor 144 and pull on the suture 122 untilthe suture anchor 144 is properly positioned. Both the stepped needle103 and sleeve 220 are withdrawn after proper deployment of the anchor144.

FIG. 47 depicts a curved disc compressor 111 with two openings 123 forthe suture 122 and a round or blunt annular compressing region 119. FIG.48 depicts knot 125 tying and bulge compression of the fastened disccompressor 111. The suture 122 is secured with full thickness anchoringby the anchor 144 and compressor 111. The bulge is compressed andfastened to alleviate pain from nerve impingement.

Two suture anchors 144 with unique suture 122 arrangement between themcan be loaded in series on a stepped needle 103 to be deployed withintissue. As the suture 122 is pulled by the surgeon, the anchors 144 drawclose to each other, pulling in or approximating the inserted tissue.FIG. 49 depicts portions of two anchors 144 connected by a suture 122through holes 123A, 123B, 123C, 123D, 123E, 123F, 123G then 123H.Proximal ends of the suture 122 are threaded through a plunger 109. Theholes 123B, 123C, 123F and 123G are angled to facilitate sliding of thesuture 122 after anchor 144 rotation. The suture 122 between the holes123D and 123E forms a stationary loop beneath the proximal anchor 144.As the suture 122 is being pulled and the plunger 109 is being pushedagainst the proximal anchor 144, the strands of suture 122 will slidefrom 123F to 123G and from 123C to 123B. With the stationary loopbeneath the proximal anchor 144, the anchors 144 will draw close to eachother to approximate, compress or plicate (fold) the inserted tissue.The distal and proximal suture anchors 144 with the suture 122 form anapproximating device 273 designed for minimally invasive use.

Two resiliently straightened anchors 144 are loaded in series on adouble-stepped 165 needle 103, as indicated in FIG. 50. Similar to FIG.49, the suture 122 is threaded through holes 123A, 123B, 123C, 123D,123E, 123F, 123G then 123H. For clarification, the suture 122 from holes123A to 123D is white and from holes 123E to 123H is black. Both whiteand black sutures 122 are slack to clarify points of origin. The distalend of the proximal anchor 144 is tapered for lateral tissuepenetration. The lumen 104 of the distal anchor 144 is smaller than thelumen 104 of the proximal anchor 144, each corresponding to the sizes ofthe distal and proximal steps 165 of the needle 103. The distancebetween the steps 165 can be pre-set or fixed to deliver the anchors144.

As the fins 134 of the distal and proximal anchors 144 snag into tissue,the needle 103 is withdrawn to deposit both anchors 144 with theconnecting suture 122, as shown in FIG. 51. Both anchors 144 resumetheir curved configuration. In vertical or insertion position, theangled suture holes 123B and 123G of the distal anchor 144 are designedto resist suture 122 sliding and to favor pivoting of the distal anchor144, as shown in FIG. 52. The rotation of the distal anchor 144 createstension on the suture 122 connecting holes 123C to 123D and 123F to123E, as shown in FIGS. 49 and 53. The tension of the sutures 122 liftsthe proximal anchor 144 by the loop beneath holes 123D to 123E, as shownin FIGS. 53 and 49. As a result, the proximal anchor 144 also rotates,laterally pressing the pointed distal end into the tissue, with the fin134 behaving like a rudder to direct rotation.

The proximal anchor 144 can also be inserted by a sliding sleeve 220,rather than by the stationary second step 165 of the needle 103. FIG. 54shows a stepped needle 103 insertion to deliver the distal anchor 144into the tissue 130. As the tissue 130 is snagged by the fin 134,partial withdrawal of the needle 103 deposits the distal anchor 144within tissue 130, as indicated in FIG. 55. The proximal anchor 144 isdelivered by pushing the sleeve 220 and pulling the suture 122, as shownin FIG. 56. Suture 122 pulling also initiates pivoting of the distalanchor 144. FIG. 57 shows complete insertion of the proximal anchor 144into the tissue 130. The needle 103 is then withdrawn to deposit theproximal anchor 144, as shown in FIG. 58, to complete the installationof the approximating device 273.

The approximating device 273 can be tightened and maintained undertension. A one-way suture lock 239 prevents backsliding during tying andallows further tightening of the suture 122 to fasten the approximatingdevice 273. FIG. 59 depicts the composition of a suture lock 239 with apair of sutures 122 passing through a hole 240 of a cone 266 into a loop267 of an one-way grip 237 with individual grippers 241, then threadedthrough a passage 238 at the proximal end of the grip 237. The suture122 passed through the loop 267 helps to direct the one-way grip 237into the cone 266. The passage 238 of the grip 237 provides a foundationfor suture knot 125 tying. The loop 267 and passage 238 also keep thepair of sutures 122 apart to obtain maximum locking strength within thecone 266. The cylindrical grippers 241 are arranged in angle, layers,sized and configured to fit within the cone 266. Each layer of thegrippers 241 are tapered, narrow at the top and widened at the base,biased against backsliding of the suture 122 but allowing further suture122 tightening. FIG. 60 shows the lock 239 assembly with the pair ofsutures 122 fastened between the cone 266 and biased grippers 241. Thepair of sutures 122 is inserted into a plunger 109. The plunger 109 isbilaterally tapered at the distal end, as shown in FIG. 60, for pushingagainst the proximal end of the one-way grip 237 without interferingwith the pulling of the suture 122 to tighten the approximating device,as shown in FIG. 61. As an optional procedure, slipknots 125 can be tiedthen delivered by a knot pusher 245 onto the proximal end of the one-waygrip 237, as shown in FIG. 62.

Cutting the excess suture 122 beneath the tissue helps to conceal theentire approximating device 273, which may be advantageous sinceexposure of the non-degradable suture 122 can promote infection. Asuture 122 cutting device 250 contains an inner tube 246 and outer tube247. FIG. 63 shows a channel open from the distal end of the inner tube246 to a side window 248 of the suture cutter 250. FIG. 64 shows theouter tube 247 also containing a side window 248. The inner tube 246 istightly fitted inside the outer tube 247 with overlapping side windows248, as shown in FIG. 65, to form the suture cutter 250. The suturecutter 250 is a relatively thin tubular device. The excess suture 122 isthreaded through the distal opening and out the overlapping side windows248 of the inner tube 246 and outer tube 247, as shown in FIG. 66. Bystraightening and holding onto the proximal ends of the excess suture122, the cutter 250 can slide along the suture 122 into tissue throughthe entry punctured by needle 103 and anchors 144. FIG. 67 shows amid-longitudinal view of the suture cutter 250 with sharp edges 249 atthe side windows 248. As the outer tube 247 slides against the innertube 246 or vice versa, the sharp edges 249 behave like scissors,cutting the sutures 122 extending out of the side windows 248, as shownin FIG. 68. FIG. 69 shows a mid-longitudinal view of suture 122 cuttingby sliding the outer 247 and inner tube 246 against each other. FIG. 70depicts suture 122 cutting with the device 250 after knot 125 tying. Thecutter 250 is then withdrawn from tissue. As a result, all componentsare concealed within the tissue to complete the installation of theminimally invasive approximating device.

One of the most common causes of anal incontinence is scarring of theexternal sphincter from childbirth. The scarred tissue 268 of theexternal sphincter 251 can be revealed beneath adipose tissue 272 withretractors 196 opening a semi-circular incision between the vagina 114and the rectum 132, as shown in FIG. 71. Currently, the scarredsphincter 251 is cut, as shown in FIG. 72. Then the scarred tissue 268is overlapped, sutured and knotted 125 to tighten around the internalsphincter 252 beneath, as indicated in FIG. 73. The tightness of thesphincteric repair is judged by the feel of the surgeon's finger. Aftersurgical repair of the sphincter 251, painful defecation is inevitable.Infection is also common.

Sphincter 251 repair can be minimally invasive using the approximatingdevices 273. To guide the needle 103 into the proper location,radiopaque, echogenic or other tracing agents can be injected through alumen 269, as shown in FIG. 74, as the needle 103 advances into thebody. Within the loosely packed adipose tissue 272, the injected tracingagent is likely to diffuse quickly. However, within highly structuredand relatively dense tissue, such as muscle, tendon, ligament or organ,diffusion of the tracing agent is limited, so it might be possible toindicate the shape of the tissue, an important criterion for verifyingthe target site for suture 122 anchoring.

The muscular external sphincter 251 encircles the rectum 132 beneath theadipose tissue 272, as shown in FIGS. 71 and 75. With guidance, theneedle 103 is laterally inserted between the vagina 114 and rectum 132to bridge both sides of the loose external sphincter 251. The needle 103can be made with a slight curvature for puncturing through skin andadipose tissue 272, then into both sides of the loose sphincter 251. Theanchors 144 can be inserted with the procedures similar to FIGS. 54 to58, positioning the pair of anchors 144 into opposite sides of the loosesphincter 251. FIG. 75 depicts tightening of the external sphincter 251by pulling the suture 122 and pushing the plunger 109 against theproximal end of the suture lock 239 at the same time, as shown in FIG.61. As a result, the approximating device 273 restricts and narrows thecircular external sphincter 251 by taking up the scarred 268 and loosetissue, as shown in FIG. 75. The sutures 122 can then be knotted 125 andcut beneath the skin, as shown in FIGS. 62, 70 and 75. The suture 122,anchors 144 and lock 239 can be made with biodegradable materials.Oozing from the sphincteric 251 muscle traumatized by insertions ofneedles 103 and suture anchors 144 can initiate permanent tissueadhesion, holding and keeping the sphincter 251 in the approximatedposition even after degradation of the suture 122 and the anchors 144.

The tips of most surgical needles are designed to cut as well aspuncture into tissue. On the other hand, for delivering theapproximating device 273 along a slender tissue, a tip without cuttingedges, similar to a sewing needle shown in FIG. 76, is preferred. Thetip with non-cutting edges is more likely to advance within a tissuewith longitudinally oriented fibers, especially accompany with rotationduring advancement. The slender tissue can be a tendon or a ligamentwith collagen bundles 270 formed lengthwise along the tissue. FIG. 77depicts the needle 103 with non-cutting edges being advanced along aligament 138 using rotational motion to drill and split a path betweencollagen bundles 270. The needle 103 can also be made with flexible orshape memory material, such as nickel-titanium alloy, to conform withinthe tendon or ligament 138. When the appropriate depth of the needle 103is reached, both the distal and proximal anchors 144 can then beindividually delivered with sleeves 220. To guide the rotational needle103 into tissue, radiopaque, echogenic or other tracing agents can alsobe injected through a lumen 269, as shown in FIG. 78.

Uterine prolapse is commonly caused by sagging ligaments. The currenttreatment is hysterectomy. FIG. 79 indicates a cross-sectional view ofuterine 161 supports. The cardinal ligament 253 provides for lateralsupport, sacrouterine ligament 254 for posterior support and fascia 255for anterior support to the uterus 161.

Similar to the hysterectomy procedure through the vagina 114 undergeneral anesthesia, the muscles and ligaments are relaxed. The uterus161 is pulled down from the vagina 114 by a grasping device 259 toexpose the cardinal 253 and sacrouterine 254 ligaments, as shown in FIG.80, with ovaries 256, fallopian tubes 258 and round ligaments 257 withinthe abdomen. Using various guiding and insertion techniques, the needle103 is advanced along the ligament 253 or 254 to deliver the anchors144, as shown in FIG. 80. The sutures 122 are loaded with suture locks239 and plungers 109. The approximating devices 273 are thenindividually tightened by advancing the plungers 109 against the suturelocks 239, while the sutures 122 are being pulled to plicate and shortenthe ligament 253 and/or 254, as shown in FIG. 81. In essence, theligament 253 and/or 254 is folded, crinkled or bunched together underthe tension of the approximating devices 273. As a result, the cervix271 and the entire uterus 161 are lifted by the shortened cardinal 253and/or sacrouterine 254 ligaments.

The shortened ligament can be permanently maintained to uphold theuterus 161. As the ligament 253 and/or 254 are traumatized by insertionsof needles 103 and anchors 144, oozing from the traumatized tissue caninitiate tissue adhesion to hold and keep the ligament 253 and/or 254 inthe plicated position even after degradation of the suture 122 and theanchors 144. The plicated ligament 253 and/or 254 also undergo tissueremodeling, including collagen crosslinking, which may also result inpermanent shortening of the ligament 253 and/or 254.

A modified procedure and a suture-gripping device are designed forfastening an anchor 144 within thin tissue. FIG. 82 depicts partialinsertion of the proximal anchor 144 of the approximating device 273into a thin tissue 130. FIG. 83 shows a prior art suture-gripping device264, with jutted flaps 265 biting and resisting upward slippage of thesuture 122. The suture-gripping device 264 loaded on the suture 122 isfollowed by the plunger 109, as indicated in FIG. 84. The needle 103 andsleeve 220 are then withdrawn from tissue 130. Similar to the proceduredepicted in FIG. 61, the sutures 122 are pulled, and the plunger 109 ispushed against the suture gripping device 264 to draw the proximalanchor 144 into the tissue 130 and tighten the approximating device 273.Then, knots 125 are tied beneath the gripping device 264 to secure thesutures 122, as shown in FIG. 85.

Accuracy of needle 103 insertion of the approximating device 273 can beimproved with a guide 185, as shown in FIG. 86. The guide 185 contains atrack 262 for the needle 103 to slide along, an extendible arm 260 toalign with the needle 103, and a pointer 261 to indicate the targetsite. In addition, measuring units on the arm 260 indicate depth ofneedle 103 penetration.

As mentioned, the traditional surgical treatment for urinaryincontinence is to provide backboard support to the urethral posteriorwall 151 by pulling the vagina 114 forward with sutures 122. The sutures122 are then fastened onto the fascia or ligament in the abdominal wall,as indicated in FIGS. 17 and 18. The approximating device 273 canprovide similar backboard support to the posterior wall 151 without anyincision 157. FIG. 87 depicts the vagina 114 is dilated with a retractor196. The needle 103 is inserted through the anterior wall of theretracted vagina 114, lateral to the bladder neck 112, through thefascia 255 or ligament into adipose tissue 272 above the pubic symphysis115. The distal anchor 144 is then deployed within the adipose tissue272 and the proximal anchor 155 within the vaginal 114 wall with thesuture-gripping device 264. The approximating device 273 is thentightened by pulling the suture 122 and pushing the plunger 109. Thetightness of the plication can be seen through the urethra 101 with anendoscope 263. The suture 122 is then knotted 125 and cut, as shown inFIGS. 85 and 88. FIG. 88 shows a minimally invasive approach tosupporting the posterior-urethral wall 151 of the urethra 101 by pullingthe vaginal 114 wall forward with approximating devices 273. Asmentioned, trauma from insertion of needles 103 and anchors 144 can leadto tissue adhesion, providing permanent posterior wall 151 support evenafter degradation of the suture 122, anchor 144 and gripping device 264.

It may also be possible to tighten the bladder neck 112 and restrict thesphincteric region of the urethra 101 without involving the ligament orfascia 255 in the abdominal wall. The needle 103 can be inserted lateralto the bladder neck 112 or the urethra 101, into the retropubic space274, area between the pubic symphysis 115 and bladder/urethra 127/101,to deliver the distal anchor 144. The proximal anchors 144 are deployedas mentioned within the vaginal 114 wall. As the approximating devices273 are tightened, the bladder neck 112 as well as the urethra 101 aresandwiched between the anterior 152 fascia and the vagina 114, as shownin FIG. 89, to tighten the bladder neck 112 and treat sphinctericdeficiency.

The most difficult step in installing the approximating device 273 isprobably the guidance of the needle 103 safely and accurately intotissue. To maximize the benefit from the effort of needle 103 insertion,multiple pairs of approximating devices 273 can be loaded or passedalong the needle 103, as shown in FIG. 90. With only a single needle 103insertion, the approximating strength is greatly enhanced with multipledevices 273 installed, as shown in FIG. 91.

The dynamics of anchor 144 pivoting or rotation responding to suture 122tension is especially significant within thin tissue 130. Fromobservation within transparent gel wax, the initial movement of a crudeprototype anchor 144 responding to suture 122 tension was in bothpullout and lateral rotational directions. A similar result was obtainedin meat. The suture 122 was not truly fastened until the prototypeanchor 144 had rotated from the insertion position to fastening orperpendicular position. Before the fastened position was achieved, thesuture 122 could be pulled with some resistance. The pivotal orrotational efficiency of the anchor 144 can probably be described by thepullout distance of the pulled suture 122. In an experiment using porkand the crude prototype anchor 144, the pullout distance was about oneand half lengths of the prototype anchor 144 before the anchor 144 wassecured. Within thin tissue, the anchor 144 would be pulled out beforereaching the fastened position. With modifications to the crudeprototype anchor 144, rotational efficiency can be significantlyimproved.

The needle 103 can also contain an inner and outer sleeves 220. Thesleeves 220 are stacked over each other, and both sleeves 220 capable ofsliding over the needle 103, as shown in FIG. 92. The lumen 104 of thedistal anchor 144 fits over the distal portion of the needle 103, buttoo small to fit over the inner sleeve 220. The slightly larger lumen104 of the proximal anchor 144 fits over the inner sleeve 220, but toosmall to fit over the outer sleeve 220. In essence, the inner sleeve 220supports the distal anchor 144 and the outer sleeve 220 supports theproximal anchor 144, with both sleeves 220 and anchors 144 fit over theneedle 103. Spearheading by the needle 103, the anchors 144 and sleeves220 are punctured into tissue. Within a proper depth into the tissue,the inner sleeve 220 is held stationary while the needle 103 ispartially withdrawn to disengage and deploy the distal anchor 144.Similarly, the outer sleeve 220 is held stationary while the needle 103is fully withdrawn to deploy the proximal anchor 144.

The fin 134 can extend beyond the length of the body 275 and be madepointed to spearhead and expedite the rotation of the suture anchor 144,as shown in FIG. 93. The side view of the pointed and extended fin 134is more evident in FIG. 94. The sharpened fin 134 helps lateralpenetration into tissue 130. Extension of the fin 134 lengthens L₁favors and expedites lateral rotation of the anchor 144. Even though L₁is significantly lengthened, the suture holes 123 are still at or nearthe center of the platform 133 to prevent excessive rotation afterreaching the fastened position.

Anchor 144 rotation begins with lateral tissue 130 penetration of thefin 134, followed by the proximal end of the body 275, then the platform134 of the anchor 144. To ease tissue 130 penetration and expediterotation, the proximal portion of the platform 133 is tapered and curvedtoward the fin 134, as shown in FIGS. 93 and 94. As the anchor 144rotates, the curved platform 133 follows the fin 134 and smoothly lodgesinto the tissue 130. The tapered proximal end of the anchor 144 issupported by a shape-matching step 165 on the needle 103, as shown inFIG. 94. The shape-matching contact between the anchor 144 and the step165 also helps to minimize spinning of the anchor 144 around thedelivering needle 103.

Location of the elastic curvature of the anchor 144 can also affect therotational efficiency. The curvature near the proximal end of the anchor144 is more likely to have better rotational efficiency than theefficiency of the curvature situated near the distal end of the anchor144.

A wide range of materials can be used to fabricate the suture anchor144. Biocompatible polymers, such as polypropylene, polyethylene,poly-ether-ether-ketone, acetal resin, polysulfone and polycarbonate,are possible candidates. For biodegradable capability, the anchor 144can be made with polylactate, polyglycolic, poly-lactide-co-glycolide,polycaprolactone, trimethylene carbonate or combinations of thesematerials. Many of these degradable polymers are in US FDA approvedproducts. Other degradable polymers, such as polydioxanone,polyanhydride, trimethylene carbonate, poly-beta-hydroxybutyrate,polyhydroxyvalerate, poly-gama-ethyl-glutamate, poly-DTH-iminocarbonate,poly-bisphenol-A-iminocarbonate, poly-ortho-ester, polycyanoacrylate andpolyphosphazene can also be used. Nickel-titanium alloy, spring-temperedstainless steel, titanium, stainless steel or other metallic materialprovides strength and durability.

The anchor 144 can also be coated with biocompatible polymers, such aspolyurethane, polytetrafluoroethylene, silicon, ultra high molecularweight polyethylene or other material. For additional biological andsurgical benefits, the anchor 144 can also be coated with lubricants,growth factors, nutrients, buffering agents, collagen, hydroxyapatite,analgesics, sealants, blood clotting agents, antibiotics, radiopaque orechogenic agents. All materials should be able to withstandsterilization by gamma, electron beam, autoclave, ETO, plasma or UVlight to prevent infection.

The stepped needle 103 and sleeve 220 can be made with stainless steel,titanium, nickel titanium other metal or alloy. The stepped needle 103and sleeve 220 can be coated with lubricant, blood clotting, radiopaqueor echogenic agents. For hard-to-reach surgical sites, the steppedneedle 103 can be made curved to gain accessibility for the surgeon. Toaccommodate the curvature of the stepped needle 103, the sleeve 220 canalso be made with elastic material, such as nickel titanium,polypropylene, polyethylene or other flexible material. The steppedneedle 103 and sleeve 220 can also be coated with lubricant, antibiotic,radiopaque or echogenic agents.

The suture 122 can be permanent or biodegradable, braided ormonofilament. The suture 122 can also be metallic for strength anddurability.

In summary, the anchor 144 is designed for partial thickness or fullthickness suture 122 anchoring and is delivered with the stepped needle103. Deployment of the anchor 144 can be as simple as inserting andwithdrawing the stepped needle 103 in and from tissue. The sleeve 220sliding over the stepped or a smooth needle 103 can be helpful indeploying the anchor 144 and manipulating tissue. The curvature of theanchor 144 promotes initial anchor 144 rotation within tissue whentension is applied to the suture 122. The fin 134 is designed to (1)dislodge the anchor 144, (2) enhance initial rotation of the anchor 144,and (3) stabilize the anchor 144 during rotation. The platform 133,especially fortified with bend stops 155, is designed to increase theanchoring strength within tissue. When multiple anchors 144 aredelivered in series into tissue, as the suture 122 is pulled, theanchors 144 draw close to each other to plicate or approximate thepierced tissue.

It is to be understood that the present invention is by no means limitedto the particular constructions disclosed herein and/or shown in thedrawings, but also includes any other modification, changes orequivalents within the scope of the claims. Many features have beenlisted with particular configurations, curvatures, options, andembodiments. Any one or more of the features described may be added toor combined with any of the other embodiments or other standard devicesto create alternate combinations and embodiments.

It should be clear to one skilled in the art that the currentembodiments, materials, constructions, methods, tissues or incisionsites are not the only uses for which the invention may be used. It hasbeen foreseen that the anchor 144 and the stepped needle 103 can beapplied in other surgical and non-surgical purposes. Differentmaterials, constructions, methods or designs for the anchor 144, steppedneedle 103 or the sleeve 220 can be substituted and used. Nothing in thepreceding description should be taken to limit the scope of the presentinvention. The full scope of the invention is to be determined by theappended claims.

What is claimed is:
 1. A method for delivering a suture anchor withintissue of the patient, the method comprising the steps of: (a)puncturing the tissue with a needle carrying a suture anchor, whereinthe suture anchor comprises a curved configuration and a straightenedconfiguration; (b) removing the needle from within the suture anchor,wherein removal of the needle causes the suture anchor to assume itscurved configuration; (c) and pulling a suture connected to the sutureanchor causing a fin on the suture anchor to snag the surroundingtissue, thereby causing said suture anchor to rotate within tissue. 2.The method of claim 1 further comprising the step of: (d) holding thesuture anchor in the tissue with a sleeve located around the needleduring step (b).
 3. The method of claim 1 used to treat urinaryincontinence, the method further comprising the steps of: (d)identifying the location of the urethra; (e) inserting the needle intothe anterior wall of a vagina of the patient lateral to the urethraduring step (a); (f) repeating steps (a) thru (e) until wall of thevagina is repositioned; (g) and tying the sutures, thereby supportingthe urethra with the repositioned wall of the vagina.
 4. The method ofclaim 1 used to treat uterine prolapse, the method further comprisingthe steps of: (d) repositioning the uterus; (e) fastening therepositioned uterus with steps (a) thru (c); (f) and repeating steps (a)thru (c) until the uterus is secure.
 5. The method of claim 1 used toreattach ligament onto bone, the method further comprising the steps of:(d) repositioning a torn ligament over bone; (e) repeating steps (a)thru (c) until the ligament is secure; (f) tying the suture; (g) andallowing the ligament heal over the bone.
 6. The method of claim 5,wherein the bone is cancellous.
 7. The method of claim 1 used to treat abulging intervertebral disc, the method further comprising the steps of:(d) inserting the needle into the bulging disc in step (a); (b) pushingthe suture anchor into the disc toward the opposite side of the bulgingdisc; (f) threading a disc compressing device onto the suture; (g)pulling and tying the suture, thereby compressing the bulging discbetween the suture anchor and the disc compressing device.
 8. The methodof claim 7, wherein step (e) is performed by using a sleeve locatedaround the needle to push the suture anchor.
 9. The method of claim 1,wherein step (b) is performed by the fin on the suture anchor snaggingon the tissue, thereby holding the suture anchor in the tissue while theneedle is withdrawn from the suture anchor.
 10. The method of claim 9,wherein a second suture anchor is located on the needle and the suturepasses through the second suture anchor and further comprising the stepsof: (d) removing the needle from the second suture anchor; (e) allowingthe second suture anchor to resume a curved configuration; (f) pullingon the suture to cause the second suture anchor to rotate within thesurrounding tissue; (g) and pulling the suture further to draw togetherthe tissue proximate the first suture anchor and the tissue proximatethe second suture anchor.
 11. The method of claim 10, wherein the firstsuture anchor is located distal to said second suture anchor.
 12. Themethod of claim 10 used to repair a loose anal sphincter, wherein instep (a), the tissue is both sides of the loose anal sphincter and step(g) narrows the sphincter.
 13. The method of claim 10 used to shorten aligament, wherein in step (a), the tissue is the ligament and step (g)shortens the ligament.
 14. The method of claim 13, further comprisingthe step of repeating steps (a) thru (g) until the ligament issufficiently shortened.
 15. The method of claim 10 used for treatingurinary incontinence, wherein in step (a), the needle passes through thevagina and into the abdominal fascia or ligament and step (g) moves awall of the vagina to support a urethral wall.
 16. The method of claim15, further comprising the step of repeating steps (a) thru (g) untilthe urethral wall is supported sufficiently to alleviate the urinaryincontinence.
 17. The method of claim 10, wherein a second pair ofsuture anchors with a second suture is located on the needle and isdeployed.
 18. The method of claim 1, wherein step (b) is performed by asleeve located around the needle holding the suture anchor in the tissuewhile the needle is withdrawn from the suture anchor.
 19. The method ofclaim 18, wherein a second suture anchor is located on the needle andthe suture passes through the second suture anchor and furthercomprising the steps of: (d) removing the needle from the second sutureanchor; (e) allowing the second suture anchor to resume its curvedconfiguration; (f) pulling on the suture to cause the second sutureanchor to rotate within the surrounding tissue; (g) and pulling thesuture further to draw together the tissue proximate the first sutureanchor and the tissue proximate the second suture anchor.
 20. The methodof claim 19, wherein step (d) is performed by the fin on the secondsuture anchor snagging on the tissue, thereby holding the second sutureanchor in the tissue while the needle is withdrawn from the secondsuture anchor.
 21. The method of claim 19, wherein step (d) is performedby the sleeve located around the needle holding the second suture anchorin the tissue while the needle is withdrawn from the second sutureanchor.
 22. The method of claim 19, wherein the first suture anchor islocated distal to said second suture anchor.
 23. The method of claim 19used to repair a loose anal sphincter, wherein in step (a), the tissueis both sides of the loose anal sphincter and step (g) narrows thesphincter.
 24. The method of claim 19 used to shorten a ligament,wherein in step (a), the tissue is the ligament and step (g) shortensthe ligament.
 25. The method of claim 24, further comprising the step ofrepeating steps (a) thru (g) until the ligament is sufficientlyshortened.
 26. The method of claim 19 used for treating urinaryincontinence, wherein in step (a), the needle passes through the vaginaand into the abdominal fascia or ligament and step (g) moves a wall ofthe vagina to support a urethral wall.
 27. The method of claim 26,further comprising the step of repeating steps (a) thru (g) until theurethral wall is supported sufficiently to alleviate the urinaryincontinence.
 28. The method of claim 19, wherein a second pair ofsuture anchors with a second suture is located on the needle and isdeployed.
 29. A method for delivering a suture anchor within tissue of apatient, the method comprising the steps of: (a) puncturing the tissuewith a needle carrying a suture anchor, wherein the suture anchorcomprises a curved configuration and a straightened configuration; (b)removing the needle from within the suture anchor, wherein removal ofthe needle causes the suture anchor to resume its curved configuration;(c) and pulling a suture connected to the suture anchor causing a fin onthe suture anchor to snag the surrounding tissue, thereby causing saidsuture anchor to rotate within tissue.